NCT01383629

Brief Summary

This RCT aims to study the effect of preoperative counselling in reducing patients fear and visual perception during vitrectomy under local anaesthesia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 28, 2011

Completed
Last Updated

June 28, 2011

Status Verified

June 1, 2011

Enrollment Period

1.2 years

First QC Date

June 27, 2011

Last Update Submit

June 27, 2011

Conditions

Any Patients Undergoing Vitrectomy Under Local Anaesthesia

Keywords

VitrectomyLocal anaesthesiaCounsellingFearVisual perception

Outcome Measures

Primary Outcomes (1)

  • Patient fear

    Patient fear during surgery is measured on a visual analogue scale

    1 week

Secondary Outcomes (1)

  • Type of visual perception during vitrectomy surgery under local anaesthesia

    1 week

Study Arms (2)

No counselling

NO INTERVENTION

normal preoperative procedures prior to vitrectomy surgery

Preoperative counselling

EXPERIMENTAL

Counselling to patient about what to expect during vitrectomy surgery under local anaesthesia

Behavioral: Counselling

Interventions

CounsellingBEHAVIORAL

Preoperative counselling

Preoperative counselling

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 18-75 years scheduled for vitrectomy under regional anaesthesia were included

You may not qualify if:

  • Patients who could not understand English, who had psychiatric illness or mental retardation, or who refused to give consent were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universiy of Malaya Medical Centre

Kuala Lumpur, 59100, Malaysia

Location

Related Publications (1)

  • Tan CS, Mahmood U, O'Brien PD, Beatty S, Kwok AK, Lee VY, Au Eong KG. Visual experiences during vitreous surgery under regional anesthesia: a multicenter study. Am J Ophthalmol. 2005 Dec;140(6):971-975. doi: 10.1016/j.ajo.2005.06.021.

    PMID: 16376638BACKGROUND

MeSH Terms

Interventions

Counseling

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 27, 2011

First Posted

June 28, 2011

Study Start

January 1, 2010

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

June 28, 2011

Record last verified: 2011-06

Locations

MY(1)